Ultrasonic treatment for wounds

ABSTRACT

A portable therapeutic device and method of use generate longitudinally propagating ultrasound and shear waves generated by such longitudinally propagating ultrasound to provide effective healing of wounds. A transducer having an operative surface is disposed substantially adjacent to the wound to emit ultrasound to propagate in the direction of the wound to promote healing. Reflections of the ultrasound by bone tissue, by skin layers, or by internally disposed reflective media propagate toward the wound as longitudinal waves, with shear waves generated by the longitudinal waves for the healing of the wound. A focusing element is used for focusing the propagation of the ultrasound at a predetermined angle toward the wound. The operative surface of the transducer may be annularly shaped to encircle the wound to convey the ultrasound and/or reflected ultrasound thereto. A housing may be provided for positioning the transducer near a portion of the skin near the wound, and for indenting the skin to form a cavity, with the transducer disposed in the cavity to emit the ultrasound toward an internal surface of the wound. Fixture structures, such as adjustable straps, may extend about a portion of the body to position the transducer near the wound.

This application is a divisional of U.S. Ser. No. 08/886,217, filed Jul.1, 1997, now U.S. Pat. No. 5,904,659, which is a continuation of U.S.Ser. No. 08/799,240, filed Feb. 14, 1997, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This disclosure relates to the non-invasive application of ultrasonicenergy to enhance and/or accelerate the process of wound healing, andmore particular, to the healing of wounds including ulcers, such asvenous ulcers.

2. Description of the Related Art

Venous ulcers on human legs have proven difficult to treat, for example,because of the lack of vascularization in and around the wound.

The term “wound” for the purposes of “wound healing”, as used throughoutthe present disclosure, includes ulcers such as venous ulcers as well asburns, ulcerated wounds due to, for example, diabetes, surgicalincisions or other surgical cuttings including stitched surgicalcuttings, skin grafts, hair transplants, revascularization, bed sores,tissue dehiscence, and ligament and tendon repair and reconstruction. Ingeneral, as used throughout the present disclosure, the term “woundhealing” encompasses addressing damage to, repair of, or restoration ofsoft tissue.

U.S. Pat. No. 4,530,360 to Duarte (hereafter “Duarte”), describes abasic therapeutic technique and apparatus for applying ultrasonic pulsesfrom an ultrasonic applicator placed on the skin at a location adjacenta bone injury. Duarte gives a range of radio frequency (RF) signals forcreating the ultrasound, ultrasonic power density levels, a range ofduration of each ultrasonic pulse, and a range of ultrasonic pulsefrequencies. The length of daily treatment is also described in Duarte.The Duarte patent is incorporated herein by reference.

U.S. Pat. Nos. 5,003,965 and 5,186,162, both to Talish and Lifshey(hereafter “Talish ′965” and “Talish ′162”, respectively) describe anultrasonic delivery system in which the RF generator and transducer areboth part of a modular applicator unit which is placed at the skinlocation. The signals controlling the duration of ultrasonic pulses andthe pulse repetition frequency are generated apart from the applicatorunit. Talish ′965 and Talish ′162 also describe fixture apparatus forattaching the applicator unit so that the operative surface is adjacentto the skin location. In one application described in Talish ′965 andTalish ′162, the skin is surrounded by a cast.

U.S. Pat. No. 5,211,160 to Talish and Lifshey (hereafter “Talish ′160”)also describes a fixture apparatus which is mounted on uncovered bodyparts; i.e. without a cast or other medical wrapping. Talish ′160 alsodescribes various improvements to the applicator unit. Each of Talish′965, Talish ′162, and Talish ′160 is incorporated herein by reference.

U.S. Pat. application Ser. Nos. 08/391,109, 08/388,971, 08/389,148, and08/367,471, entitled Gel Containment Structure, Locator Method andApparatus, Apparatus for Ultrasonic Bone Treatment, and Acoustic Systemfor Bone-Fracture Therapy, respectively, provides ultrasonic apparatusand methods which are applicable to wound healing. U.S. Pat. applicationSer. Nos. 08/391,109, 08/388,971, 08/389,148, and 08/367,471 areincorporated herein by reference.

In general, an ultrasound carrier frequency between 20 kHz and 10 MHzcoupled with a relatively low-frequency modulating signal, such as 5 Hzto 10 kHz, and a spatial peak temporal average acoustic intensity, suchas an intensity less than about 100 milliwatts/cm², should aid in andshould be effective in wound healing.

Heretofore, such techniques have not been applied to heal wounds byinternal application of ultrasound, such as using reflection ofultrasonic waves by reflection from internal tissue such as bone.

SUMMARY

It is herein recognized that both longitudinally propagating ultrasoundand shear waves generated by a transducer mechanism and/or by suchlongitudinally propagating ultrasound provide effective healing ofwounds.

A portable therapeutic device and method of use thereof for healing awound includes a transducer having an operative surface, with thetransducer, disposed substantially adjacent to the wound to emitultrasound to propagate in the direction of the wound for the healingthereof. Reflections of the ultrasound by bone tissue and by skin layerspropagate toward the wound as longitudinal waves for the healingthereof, and shear waves are generated by the longitudinal waves and/orthe reflected longitudinal waves for the healing of the wound.

The transducer may include an axis and a focusing element for focusingthe propagation of the ultrasound at a predetermined angle with respectto the axis, with the focused ultrasound propagating toward the woundfor the healing thereof.

Alternative configurations of the operative surface of the transducerinclude an annularly shaped operative surface for emitting theultrasound therefrom, with the wound encircled by the operative surfacefor receiving the ultrasound and/or reflected ultrasound.

A housing may be provided for positioning the transducer substantiallyadjacent to a portion of the skin substantially adjacent to the wound,and for causing the portion of the skin to form a cavity, with theoperative surface of the transducer disposed in the cavity to emit thisultrasound to an internal surface of the wound for the healing thereof.

Reflective media may be internally disposed within the body having thewound for reflecting the ultrasound from the transducer to propagatetoward the wound for the healing thereof. Fixture structures, extendingabout a portion of the body having the wound, may also be provided forpositioning the transducer substantially adjacent to the skinsubstantially adjacent to the wound. The fixture structure may includean adjustable strap.

In other embodiments, the transducer may be a rod-shaped operativesurface having an axis for emitting the ultrasound radially toward thewound for the healing thereof.

Using the disclosed therapeutic devices, wounds are safely and simplytreated, with such wounds as venous ulcers responsive to therapeuticultrasound to be healed effectively. Such therapeutic devices andmethods of use provide for wound treatment by modest adaption ofexisting devices for delivering ultrasound in therapeutic settings.

In one embodiment, a device is provided for delivering anultra-high-frequency carrier signal for low power excitation of anacoustic transducer which is acoustically coupled to a limb or otherpart of a living body. The transducer is positioned adjacent an externalskin location in the vicinity of the external border of the wound on theskin to provide a surgical, non-invasive transcutaneous delivery of atleast part of its acoustic energy directed from the external skinlocation toward a portion of a bone located within the body in thevicinity of the boundary of the wound internal to the body. The boundaryof the wound internal to the body is also referred to herein as theinternal or interior surface of the wound.

Once the acoustic energy enters the body, it passes into internal bodytissue and/or fluids. The acoustic energy, in the form of ultrasonicpulses, is reflected off the surface of underlying bone or otherultrasound reflective material, and the reflected ultrasound travelstoward at least part of the internal surface or underside of the wound.Healing of the wound at the internal surface by the generation ofepithelial cells is enhanced via the acoustic stimulation.

Preferably, a low frequency signal which is present as a modulation ofthe carrier frequency is transmitted from the ultrasonic transducer,through interposed soft tissue, and onto the surface of the bone. Thecarrier wave incident on the bone surface, or other reflection surfacesin the body, is reflected toward the internal surface of the wound. Whenthe carrier wave impinges the internal surface of the wound, at least aportion of the carrier wave is converted into therapeutically beneficialshear waves of acoustic energy, flooding a region of the internalsurface of the wound. The shear waves increase vascularization at theinternal surface of the wound, thus enhancing growth of epithelialcells. The epithelial cell growth represents healing of the wound. Thetechnique thus promotes healing of the wound from the internal surfaceof the wound.

The number, position, and size of ultrasonic applicators used at theexternal skin location are chosen based on the size and position of thewound, and the relative position and proximity of the bone from whichthe ultrasonic waves are reflected. One or more ultrasonic therapytreatments per day, each having a duration of approximately 20 minutes,is suitable.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the disclosed therapeutic ultrasound apparatus andmethod will become more readily apparent and may be better understood byreferring to the following detailed description of an illustrativeembodiment of the present invention, taken in conjunction with theaccompanying drawings, where:

FIG. 1 is a cut-away perspective view showing a device and method of usethereof for wound healing;

FIG. 2 is a side view of an embodiment of an ultrasound transducer;

FIG. 3 is a side cross-sectional view of the device using a focusingattachment;

FIG. 3A is a cut-away perspective view of an alternative embodiment ofthe transducer configured to have an annular shape and a woven fabriccovering;

FIG. 4 is a frontal view of a typical wound disposed on a torso;

FIG. 5 is a cut-away perspective view of the wound healing devicedisposed near the wound in the torso;

FIG. 6 is a cut-away perspective view of the wound healing deviceapplied to a wound in conjunction with a gel bladder;

FIG. 7 is a cut-away perspective view of the wound healing devicecausing an indentation of the torso to orient the transducer for healingthe wound;

FIG. 8 is a cut-away perspective view of the wound healing deviceoperating in conjunction with an internally disposed reflecting medium;

FIG. 9 is a cut-away perspective view of an alternative configuration ofthe wound healing device having an annular configuration and a wovenfabric covering and operating in conjunction with an internally disposedreflecting medium;

FIG. 10 is a cut-away perspective view of an alternative configurationof the wound healing device having a rod-like configuration;

FIG. 11 is a cut-away perspective view of an alternative configurationof the wound healing device having an annular configuration without awoven fabric covering; and

FIG. 12 is a perspective view of an alternative configuration of thewound healing device attachable to a thigh for healing a woundthereupon.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now in specific detail to the drawings, with like referencenumerals identifying similar or identical elements, as shown in FIG. 1,the present disclosure describes an apparatus 10 and method of usethereof for wound healing, which includes an ultrasonic generator 12 andone or more ultrasonic applicators 14, which include ultrasonictransducers 16 known in the art, for applying ultrasonic waves 18, 20 toa wound 22, such as an ulcer. More than one applicator 14 or transducer16 may be used to stimulate larger wounds, as needed. The spatial peaktemporal average acoustic intensity of the applicators 14 is betweenabout 5 mW/cm² and about 100 mW/cm². The carrier frequency and intensityof the ultrasonic treatment is selected by taking into account suchfactors as: (1) the amount of soft tissue interposed between theexternal skin location, where the ultrasonic applicator 14 ispositioned, (2) the position and cross-section of the bone site 24 fromwhich the ultrasonic waves 18 are reflected, (3) the amount of softtissue interposed between the bone 26 and the internal surface 28 of thewound 20, and (4) the size, topography and medical characteristics ofthe internal surface 28 of the wound 20, and, consequently, shear wavesor surface acoustic waves (SAW) and longitudinal waves to be generatedat the site.

The carrier wave is modulated with an audio signal approximately between5 Hz and 10 Khz. Low level ultrasound delivers a primary wave called thelongitudinal wave 30, which is emitted by the transducer 16 of theapplicator 14 as shown in FIG. 1. There are also shear waves or SAW 32generated by the ultrasound from the transducer 16 which radiate outwardalong the skin surface. The primary longitudinal wave 30 is partiallyincident on a bone 26 in the body, and so is partially reflected at areflection site 24 to generate a reflected portion 34, with thereflected portion 34 directed toward the internal surface 28 of thewound 22. The primary longitudinal wave 30 may also be reflected byother surfaces. For example, as shown in FIG. 1, the internal layer 36of skin on the opposite side of a limb to the transducer 16 may providea reflective surface to thus generate additional reflected longitudinalwaves 38 directed from the opposite internal skin layer 36 to the wound22.

When the reflected longitudinal waves 34, 38 impinge on the internalsurface 28 of the wound 22, such reflected longitudinal waves 34, 38 areat least partially converted to shear waves or SAW 32 in and around theinternal surface 28 of the wound 22, which enhance wound healing at theinternal surface 28 by stimulating cell production by the mesenchymalline, thus promoting vascularization and epithelialization.

As shown in the illustrative embodiment in FIG. 1, the ultrasonicapplicator 14, including the transducer 16 configured as a modular unit,is placed adjacent an external skin location 40 in the vicinity of theexternal border of the wound 22. A gel bladder 42, or alternatively aloose conducting gel or other ultrasound conducting media, is positionedbetween the transducer 16 and the external skin location 40. As shown inFIG. 1, the ultrasound which is transmitted into the soft tissue mediumin the form of longitudinal waves 30 diverges as it moves toward thebone 26 or other surfaces such as the skin layer 36 providingreflection. The reflected ultrasound, in the form of longitudinal waves34, 38, continues to diverge as it approaches the internal surface 28 ofthe wound 22, so that the ultrasonic treatment delivered to the generalsite of the wound 22 covers a relatively large region of the internalsurface 28 of the wound 22.

Alternatively, as shown in FIG. 2, the transducer 16 may have anattachment, typically positioned between the operative surface 46 of thetransducer 16 and the gel bladder 42, which acts as a focusing elementto focus the ultrasound emitted from the operative surface 46 into thesoft tissue. In another embodiment, the transducer 16 may be configuredto have the focusing element integrally formed with the transducer 16.FIG. 3 shows a side view of the transducer housing of FIG. 2 showing thetransducer 16 including the focusing element, illustratively embodied asthe attachment 44. Thus, the ultrasound emitted from the transducer 16in the form of a primary longitudinal wave 30 may be directed at anangle 48 with respect to an axis 50 associated with the transducer andthence toward the bone 26 or other reflective surfaces when theultrasound enters the soft tissue. The reflected waves 34, 38 alsoremain relatively focused.

The reflected longitudinal waves 34, 38 may generate respective sets ofshear waves or SAW for providing a combined therapeutic treatment to thewound 22. As shown in FIG. 3, the reflected longitudinal wave 34 createdby reflection of the primary longitudinal wave 30 off the bone 26 isincident on a portion of the internal surface 28 of the wound 22, thuscreating a first set of shear waves 52. The reflected longitudinal wave38 created by the reflection of the primary longitudinal wave 30 off theopposite side layer 36 of tissue is incident on a separate portion ofthe wound 22, thus creating a second set of shear waves 54. In additionto this technique, the angle 48 of the ultrasonic emission may be sweptand/or modified, either physically or electronically, so that differentregions of the internal wound surface 28 may be treated.

In either technique, two or more transducers may be used, as determinedby the size, length, etc. of the wound 22. Generally, multipletransducers may be provided at a number of external skin locationsaround the wound 22 in order to increase the effectiveness of theultrasonic therapy reflected to the internal surface 28 of the wound 22.

In the illustrative embodiments of FIGS. 1-3, the ultrasonic head moduleof the ultrasonic applicator 14 includes the transducer 16 of anultrasonic treatment apparatus. For clarity, the fixture structure whichholds the head module adjacent the external skin location 40 is omitted.Also omitted are the electronics and other features which ultimatelyprovide the excitation signals for the transducer 16. These aredescribed in further detail in the above-referenced patents and patentapplications, which have been incorporated by reference.

Alternatively, or in conjunction, the at least one ultrasonic applicator14 may be moved, or may be configured to be movable, to a differentexternal skin location adjacent the wound 22 in order to providetreatment to various portions of the wound 22. Varying the position ofthe at least one ultrasonic applicator, including moving the transducer16 circularly or linearly along the skin, also provides treatment ofvarying intensity at portions of the wound 22.

The transducer 16 itself may also be configured to vibrate with respectto a given external skin location, so that the longitudinal waves 30generated therefrom and transmitted through the soft tissue are moreuniform, thus providing more uniform treatment, including more uniformshear waves, at the internal wound surface 28 where the reflectedlongitudinal waves 34, 38 impinge. The transducer 16 may be made tovibrate with respect to a housing (not shown in FIGS. 1-3 for clarity)which holds the transducer 16 adjacent an external skin location toaccomplish such uniformity of longitudinal waves 30.

The focusing of ultrasonic waves described with respect to FIGS. 2-3above is illustratively shown with a substantially planar operativesurface 46 and a substantially conical attachment 44. In alternativeembodiments, the focusing of ultrasonic waves may be provided byconfiguring the transducer 16 with non-planar surfaces such asnon-planar operative surfaces or non-planar segments to generate andemit ultrasound with different propagation characteristics in order toallow differing patterns and intensities of ultrasonic waves to betransmitted toward the internal surface 28 of the wound 22. Thisprovides a variety of therapeutic ultrasonic stimulation and treatmentat the internal surface 28.

For example, the transducer segments may be pie shaped, annular rings,or other configurations, which may be activated separately or in unison.Alternatively, or in conjunction, the transducer 16 may be provided witha modal converter or transducer lens, which may also change the patternof the ultrasound emitted from the transducer 16.

The carrier frequency and/or the modulating frequency may also be variedor swept through a range of frequencies in order to provide a variety oftreatments to the internal wound surface 28. The frequencies may bevaried either in a continuous manner, or discrete changes may be made inthe applied frequency. Varying the carrier and/or modulating frequencyis especially useful in applying ultrasonic treatment to promote avariety of stages of cell regeneration in approximately the same regionduring the same therapy session.

In an alternative embodiment, FIG. 3A illustrates treatment of a wound22 such as a venous ulcer as in FIGS. 1-3, but utilizing anannular-shaped transducer 56 having a curved operative surface 58 (shownin a cut-away perspective view in FIG. 3A) composed of a compositepiezoelectric material attached by a connector 60 to an ultrasonicgenerator (not shown in FIG. 3A), in which the composite piezoelectricmaterial disposed in a woven fabric 62 or a semi-permeable memberprovides ultrasonic conductivity between the transducer 56 and the skinof the patient. The woven fabric 60 may have either a hard or a pliableconstruction, and may be composed of material conductive of ultrasound.Alternatively, the woven fabric 60 may be porous for retaining andreleasing ultrasound conductive gel.

The transducer 56 is cut or constructed to surround the external surfaceof the wound 22. When the appropriate RF signals are applied, thecomposite piezoelectric material of the transducer 56 emits ultrasonicwaves having the therapeutic parameters previously described. Primarylongitudinal waves 64, 66 are emitted from the composite piezoelectricmaterial into the body, as shown in FIG. 3A, and reflected from thesurface of the bone 26 or from other reflective interfaces, to generatereflected longitudinal waves 68, 70, respectively, which are directedonto the internal surface 28 of the wound 22, thus creating therapeuticshear waves 72, 74, respectively. It is understood that the compositepiezoelectric material may completely surround the wound 22; thus, theprimary longitudinal waves 64, 66 are emitted from around the entirewound, reflected from the reflecting material, and incident on theinternal surface 28 of the wound 22, thereby flooding the internalsurface 28 of the wound 22 with the induced shear waves 72, 74.

While the embodiments of the present invention described above refer tothe reflection of a primary longitudinal wave from a bone to an internalsurface of a wound, the present invention also encompasses delivery ofultrasound to the internal surface of the wound where there is no boneor other reflecting surface in the vicinity of the wound, as describedbelow in further detail with reference to FIGS. 4-11.

FIG. 4 illustrates the front of a male torso 76 having a wound 78 on thestomach. The views illustrated in FIGS. 5-11 are cross-sectional viewsof FIG. 4 taken across lines 5—5. As shown in FIG. 5, a transducer 80 ispositioned in a transducer housing 82 disposed upon the external skin ofthe torso 76 adjacent to the external border of the wound 78, and alongitudinal wave 84 emitted from the transducer 80 penetrates far intothe body before it is reflected off a surface internal to the torso 76such as the spine or any internal organs such as the lungs, stomach, orintestines, which may contain gases such as air, with reflectedlongitudinal waves then directed onto the internal surface 86 of thewound 78. This is especially true when the person is overweight, or whenthe cross-section of available reflecting surfaces is small and/oruneven. The longitudinal wave 84 may provide some therapeutic healing ofthe wound 78, but the intensity of the reflected wave incident on theinternal surface 86 of the wound 78 may be too attenuated to provide thenecessary therapeutic treatment.

FIG. 6 shows an alternative method and embodiment of treating suchwounds of the torso 76, in which a gel bladder 88 is interposed betweenthe external surface of the wound 78 and the operative surface of thetransducer 80. The longitudinal wave 84 emitted from the transducer 80travels directly through the gel bladder 88 and into the wound 78, thuscreating a shear wave 90 when the longitudinal wave 84 is incident onthe internal surface of the wound 78. The gel bladder 88 is to besterile, especially if the wound 78 is open, and may be impregnated withmedication, such as an antibacterial ointment, which flows into thewound 78 and/or its surface during the ultrasonic treatment.

FIG. 7 illustrates another method and device for treating the wound 78of a torso 76, in which the transducer 80 is pressed against theexternal surface of the lower torso, such as approximately adjacent thestomach, to be positioned near the wound 78. By pressing the transducerhousing 82 against the external region of the stomach, a localindentation 92 is created. The transducer housing 82 may be turned as itis pressed inward, so that the operative surface 94 of the transducer 80is directed in the general direction toward the internal surface 96 ofthe wound 78 within the indentation 92. As shown, the longitudinal wave98 emitted is incident directly on at least a portion of the internalsurface 96 of the wound 78, thus inducing therapeutic shear waves 100.If a specially configured transducer, or alternatively a transducerattachment 102, is used, such as shown in FIG. 3, for focusing theultrasound in a specific direction, the longitudinal wave 98 may beemitted off of a center axis 104 of the transducer 80, for example, in adirection toward the internal surface 96 of the wound 78, without theneed for turning the transducer housing 82 as it is pressed against theskin.

FIG. 8 illustrates another method and device for treating a wound 78, inwhich a reflecting medium 106 is inserted into the body in the proximityof the internal surface 96 of the wound 78. The properties of thereflecting medium 106 provide for the reflection of the longitudinalwave 108 toward the internal surface 96 of the wound 96, as if a bonewere present, such as described above with reference to FIGS. 1-3A. Thereflecting medium 106 may be composed of a variety of materials, and maybe fixed in the body or inserted temporarily. For example, thereflecting medium 106 may be a metallic plate, a gas filled pouch, orother quasi-permanent inserts. The reflecting medium 106 may be also be,for example, a contrast agent composed of, for example, bubbles in agelatin, which is injected intravenously prior to the treatment. In oneembodiment, the contrast agent may be absorbable by the body in arelatively short period, thus the contrast agent acts as a temporarilyinserted reflecting medium.

An inserted reflecting medium 106, as described with respect to FIG. 8above, performs particularly well in conjunction with a piezoelectricultrasonic material or device. As shown in FIG. 9, the piezoelectricultrasonic device 110 may be embodied as the device 56 described abovewith respect to FIG. 3A. The piezoelectric ultrasonic device 110 may beconfigured to surround the exterior boundary of the wound 78. As shownin FIG. 9, illustrative examples of the longitudinal waves 112, 114generated from the piezoelectric ultrasonic device 110 surrounding thewound 78 are reflected off of an internally disposed medium 116 and ontothe internal surface 96 of the wound 78, thereby generating therapeuticshear waves (not shown in FIG. 9) at the internal surface 96 of thewound 78. It is understood that the piezoelectric ultrasonic device 110completely surrounds the wound 78; thus, longitudinal waves not limitedto the illustrative examples of longitudinal waves 112, 114 are emittedaround the entire wound 78, reflected from the reflecting material 116,and incident on the internal surface 96 of the wound 78, to flood theinternal surface 96 of the wound 78 with induced shear waves.

In an alternative embodiment shown in FIG. 10, an ultrasonictransmitting rod 118 is provided which emits at least one longitudinalwave 120 radially from the axis of the ultrasonic transmitting rod 118.The rod 118 may be composed of, for example, a composite piezoelectricmaterial, and the rod 118 is secured to the patient by a harnessapparatus 122, 124 such that the rod 118 is pressed against the skinadjacent the wound 10, and a portion of the longitudinal wave 120 isincident on the internal surface 96 of the wound 78, thus inducingtherapeutic shear waves (not shown in FIG. 10).

In another alternative embodiment shown in FIG. 11, an ultrasonictransmitting ring 126 is provided which emits longitudinal waves 128,130 radially from the surface of the ring 126. The ring may be composedof, for example, a composite piezoelectric material, and may beconfigured in a manner similar to the piezoelectric ultrasonic devices56 and 110 in FIGS. 3A and 9, respectively, without the woven fabric toact as an ultrasonic conductor. Accordingly, ultrasonic conductive gelmay be used with the ring 126 of FIG. 11. With the ring pressed againstthe skin surrounding the wound 78, a portion of the longitudinal waves128, 130 emitted from the ring 126 is incident on the internal surface96 of the wound 78, thus inducing therapeutic shear waves 132, 134. Itis understood that the ring 126 may be configured to completelysurrounds the wound 78; thus, longitudinal waves including theillustrative longitudinal waves 128, 130 are emitted from around theentire wound 78 and incident on the internal surface 96 of the wound 78,to flood the internal surface 96 of the wound 78 with induced shearwaves 132, 134.

In an alternative configuration shown in FIG. 12, the wound healingdevice 136 includes a transducer 138 positioned in a housing 140 whichis secured by an adjustable securing structure 142 to a thigh forhealing a wound 78 thereupon, with the transducer 138 emittinglongitudinal ultrasonic waves 144 which generate shear waves (not shownin FIG. 12) upon contact with the internal surface of the wound 78. Inan illustrative embodiment, the adjustable securing structure 142 shownin FIG. 12 includes an adjustable strap 146 having a first portion 148engaging a second portion 150 using hook and link fasteners, such as“VELCRO”. Alternatively, a belt with a buckle and notches may be used,or a sterile adhesive strip for adhering to the thigh.

As noted above, the term “wound” as used herein, has a broad meaning,generally encompassing addressing damage to, repair of, or restorationof soft tissue. The present invention may be used, for example, toprevent surgical adhesions, by stimulating the proper repair of surgicalincisions. It may also prevent or arrest wound dehiscence, by promotingvascularization at the surfaces adjacent surgical incisions. It may alsobe used in cosmetic surgery, for example, by enhancing the healing ofhair transplants, or by directly stimulating regeneration of cells.

Accordingly, modifications such as those suggested above, but notlimited thereto, are to be considered within the scope of the invention.

What is claimed is:
 1. A method of promoting healing of a body wound,wherein the body includes an interior body region, which is adjacent tothe wound and which extends within the body and away from the wound,comprising: positioning an ultrasonic transducer on a surface of thebody, wherein the transducer has an operative surface disposed to directultrasonic waves toward the interior body region; positioning areflective medium within the body; emitting ultrasonic waves from theoperative surface of the ultrasonic transducer onto the reflectivemedium, whereby the reflective medium redirects at least a portion ofthe ultrasonic waves toward the wound sufficient to promote healing ofthe wound.
 2. The method of claim 1, wherein positioning the reflectivemedium within the interior body region comprises fixing the reflectingmedium in the body substantially adjacent to the body wound.
 3. Themethod of claim 1, wherein the emitting of ultrasonic waves is at aspatial peak temporal average acoustic intensity ranging from about 5mW/cm² to about 100 mW/cm².
 4. The method of claim 1, wherein theportion of ultrasonic waves redirected toward the wound providessufficient longitudinal waves to generate shear waves or surfaceacoustic waves at the body wound.
 5. The method of claim 1, whereinpositioning the reflective medium within the body comprisesintravenously injecting the reflective medium into the body.
 6. Themethod of claim 1, wherein the reflective medium is inorganic.
 7. Themethod of claim 6, wherein the reflective medium is a metallic plate. 8.The method of claim 1, wherein the reflective medium is a gas filledpouch.